HysterectomyDARSHNCT07233811
Day Care in Robotic Surgery Hysterectomy. Investigate Quality of Life and Safety With Same Day Discharge After Robotic Hysterectomy for Patients With Benign and Malignant Disease. A Multicenter Randomized Study With 3 Hospitals in Stockholm Sweden.
A study testing Day care and Overnight stay in people with Hysterectomy and Same Day Discharge, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
Patients undergoing robotic assisted hysterectomy in three different hospitals in Stockholm will be randomized to day-care (going home the same day as the surgery) or admission (staying at least one night after surgery). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Hysterectomy, Same Day Discharge, Robotic Surgical Procedures
- What is being tested?
- Day care and Overnight stay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Jan 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient that are planned to undergo total robotic hysterectomy with or without adnexal surgery at the three sites.
- Both benign conditions and endometrial cancer.
- All BMI groups and all uterus sizes.
Who cannot join
- Age not over 75 years old,
- No company at home first night after surgery
- ASA class 3 that is not only because of high BMI.
- Simultaneous prolapse surgery/lymph node evacuation.
- Severe endometriosis or patients with chronic pain conditions that have a special pain regimen after surgery.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Södersjukhuset
Stockholm, 11447
Emily Rebecka Benér, MD, +460705554427, emily.bener@ki.se
Malin Brunes, MD, PhD, malin.brunes@ki.se
- Recruiting
Danderyd Hospital
Stockholm
Ulrika Johannesson, MD, Docent, +460812355000, ulrika.johannesson@ki.se
Emily Benér, MD, emily.bener@ki.se
- Recruiting
Karolinska University hospital
Stockholm
Vilhelm Mörlin, MD, +460812380000, vilhelm.morlin@regionstockholm.se
Emily Benér, MD, +46705554427, emily.bener@ki.se
About this study
Official title: DARSH - A Multicenter Randomized Controlled Trial: Day-care vs Overnight Stay in Robotic Assisted Hysterectomy in Patients With Bening Disease and Endometrial Cancer.
Patients undergoing robotic assisted hysterectomy in three different hospitals in Stockholm will be randomized to day-care (going home the same day as the surgery) or admission (staying at least one night after surgery). The aim with this study is to investigate if patients in day-care recover as fast/faster as the other group that stays in the hospital. Both patients with benign disease and malign disease (endometrial cancer) will be included in the study.
Patients quality of life (QoL) will be measured before surgery and after surgery at day 3,7 and 30 with a questionnaire called Eq-5D-5L from Euroqol. The questionnaire is validated for postoperative QoL and widely used.
Complications due to surgery within the 30 first days after surgery will also be recorded in the two groups to make sure it is safe for the patients to go home the same day as their surgery.
Read the detailed description
The study is a multicenter randomized non-inferiority trial. Three hospitals will participate in the study, Södersjukhuset and Danderyds sjukhus for benign indications, and Karolinska Sjukhuset Solna in case of endometrial cancer. The experimental group consisting of patients undergoing same-day discharge, while the control group consisting of patients admitted overnight. The study will use a 1:1 randomization ratio between the experimental and the control group with stratification for malignant and benign cases, given that Karolinska University Hospital Solna only handles endometrial cancer cases, while the other two sites handle benign cases exclusively.
To measure Quality of Life, the validated Euroqol instrument EQ-5D-5L will be used. The EQ-5D-5L instrument is well validated and used in several studies. The literature support that a 5 points difference at the visaul analog scale (VAS) scale is significant for better/worse health QoL.
To measure patient satisfaction with the length of hospital stay and care given they will at day 30 receive an additional questionnaire, the "Quality in patent perspective" (QPP), which is a validated questionnaire in Swedish.
- Being tested
- Day care, Overnight stay
- Keywords
- Hysterectomy, Same day discharge, Robotic assisted Hysterectomy, Robotic suregery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day careOther
The patient return to home the same day as the surgery is performed.
Overnight stayOther
The patient spend the night at the hospital and can not go home until the next morning.
| Study group | Role | What they receive |
|---|---|---|
| Day care | Experimental | The patient returns to home the same day as the surgery is performed (before midnight) Receives: Other: Day care |
| Overnight stay | Active comparator | The patient stay at the hospital overnight after their surgery. Receives: Other: Overnight stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QoL) day 3 after surgery compared to before surgery
Patients self reported quality of life (QoL) at a visual analog scale (VAS-scale) as reported in the 5-level EQ-5D Euroqol form (Eq-5d-5L) before surgery, compared with day 3 after surgery. The VAS-Scale goes from 0 to 100 where 0 i labeled "The worst health you can imagine" and 100 is labeled "The best health you can imagine". Compared between the two groups: day care and overnight stay.
Measured: 3 days
Secondary outcomes (8)
Quality of life (QoL) day 30 after surgery.
The patients self-reported value at the VAS-Scale (0-100) as reported in the EQ-5D-5L questionnaire at day 30 compared to their value before surgery.
Measured: 30 days
Patient satisfaction with length of stay
Patient satisfaction with length of stay from the QPP (quality from patients perspective) questionnaire after 30 days.
Measured: 30 days
Eq5D-5L index value of QoL.
The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. These five questions generate an index value ranging from -0,59 to 1, where 1 signifies excellent health and below 0 is worse than death.
Measured: 30 days
Complications after surgery
Complications within 30 days from surgery according to Clavien-Dindo (grouped as None, Grade 1-2, Grade 3 or Grade 4).
Measured: 30 days
Readmission
Readmission to the hospital within 30 days (yes/no
Measured: 30 days
Reoperation
Reoperation within 30 days (yes/no)
Measured: 30 days
Sick leave after suregery
Length of sick leave after operation, information from the Swedish Social insurance system.
Measured: 60 days.
Socioeconomic costs
Socioeconomic cost, "Quality-adjusted life years" (QALY´s). The cost is calculated from the patients Eq5D-5L ratio combined with sick leave and costs for the surgery and care at hospital.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malin Brunes, Karolinska Institutet
- Investigators
- Malin Brunes, MD,PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233811
- Sponsor's protocol ID
- 2023-05648-01
- Other IDs
- 2023
- Acronym
- DARSH
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data that underlie the reported results.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DARSH - A Multicenter Randomized Controlled Trial: Day-care vs Overnight Stay in Robotic Assisted Hysterectomy in Patients With Bening Disease and Endometrial Cancer.
- ClinicalTrials.gov ID
- NCT07233811
- Acronym / sponsor ID
- DARSH / 2023-05648-01
- Keywords
- Hysterectomy, Same day discharge, Robotic assisted Hysterectomy, Robotic suregery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing robotic assisted hysterectomy in three different hospitals in Stockholm will be randomized to day-care (going home the same day as the surgery) or admission (staying at least one night after surgery). The aim with this study is to investigate if patients in day-care recover as fast/faster as the other group that stays in the hospital. Both patients with benign disease and malign disease (endometrial cancer) will be included in the study.
Patients quality of life (QoL) will be measured before surgery and after surgery at day 3,7 and 30 with a questionnaire called Eq-5D-5L from Euroqol. The questionnaire is validated for postoperative QoL and widely used.
Complications due to surgery within the 30 first days after surgery will also be recorded in the two groups to make sure it is safe for the patients to go home the same day as their surgery.
Detailed description
The study is a multicenter randomized non-inferiority trial. Three hospitals will participate in the study, Södersjukhuset and Danderyds sjukhus for benign indications, and Karolinska Sjukhuset Solna in case of endometrial cancer. The experimental group consisting of patients undergoing same-day discharge, while the control group consisting of patients admitted overnight. The study will use a 1:1 randomization ratio between the experimental and the control group with stratification for malignant and benign cases, given that Karolinska University Hospital Solna only handles endometrial cancer cases, while the other two sites handle benign cases exclusively.
To measure Quality of Life, the validated Euroqol instrument EQ-5D-5L will be used. The EQ-5D-5L instrument is well validated and used in several studies. The literature support that a 5 points difference at the visaul analog scale (VAS) scale is significant for better/worse health QoL.
To measure patient satisfaction with the length of hospital stay and care given they will at day 30 receive an additional questionnaire, the "Quality in patent perspective" (QPP), which is a validated questionnaire in Swedish.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day care | Experimental | Other: Day careThe patient returns to home the same day as the surgery is performed (before midnight) |
| Overnight stay | Active comparator | Other: Overnight stayThe patient stay at the hospital overnight after their surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient that are planned to undergo total robotic hysterectomy with or without adnexal surgery at the three sites.
- Both benign conditions and endometrial cancer.
- All BMI groups and all uterus sizes.
Key exclusion criteria (5 listed)
- Age not over 75 years old,
- No company at home first night after surgery
- ASA class 3 that is not only because of high BMI.
- Simultaneous prolapse surgery/lymph node evacuation.
- Severe endometriosis or patients with chronic pain conditions that have a special pain regimen after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day careThe patient return to home the same day as the surgery is performed. | Other | Day care |
| Overnight stayThe patient spend the night at the hospital and can not go home until the next morning. | Other | Overnight stay |
Primary outcome
Quality of life (QoL) day 3 after surgery compared to before surgery
Time frame: 3 days
Patients self reported quality of life (QoL) at a visual analog scale (VAS-scale) as reported in the 5-level EQ-5D Euroqol form (Eq-5d-5L) before surgery, compared with day 3 after surgery. The VAS-Scale goes from 0 to 100 where 0 i labeled "The worst health you can imagine" and 100 is labeled "The best health you can imagine". Compared between the two groups: day care and overnight stay.
8 secondary outcomes
Quality of life (QoL) day 30 after surgery.
Time frame: 30 days
Patient satisfaction with length of stay
Time frame: 30 days
Eq5D-5L index value of QoL.
Time frame: 30 days
Complications after surgery
Time frame: 30 days
Readmission
Time frame: 30 days
Reoperation
Time frame: 30 days
Sick leave after suregery
Time frame: 60 days.
Socioeconomic costs
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data that underlie the reported results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malin Brunes, MD,PhD principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day care and Overnight stay in people with Hysterectomy and Same Day Discharge, run by Karolinska Institutet at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Benér, MD (+46705554427, emily.bener@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QoL) day 3 after surgery compared to before surgery (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.